Scientifically rigorous clinical trials are needed to test continuous positive airway pressure’s (CPAP) effect on important clinical endpoints known to be associated with obstructive sleep apnea, such as myocardial infarction, cardiac arrhythmias, stroke, mortality, seizures, and cognitive function. In this “Special Article,” we review the regulatory and ethical issues that surround the design and conduct of CPAP trials, including selection of the appropriate control condition, exclusion criteria, and follow-up duration. CITATION: Brown DL; Anderson CS; Chervin RD; Kushida CA; Lewin DS; Malow BA; Redline S; Goldman EB. Ethical issues in the conduct of clinical trials in obstructive sleep apnea. J Clin Sleep Med 2011;7(1):103-108.
- Utilization of Healthcare Resources in Obstructive Sleep Apnea Syndrome: a 5- Year Follow-Up Study in Men Using CPAP
- Randomized Controlled Trial of Variable-Pressure Versus Fixed-Pressure Continuous Positive Airway Pressure (CPAP) Treatment for Patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
- Practice Parameters for the Surgical Modifications of the Upper Airway for Obstructive Sleep Apnea in Adults
- Use of Flow–Volume Curves to Predict Oral Appliance Treatment Outcome in Obstructive Sleep Apnea
- Relationship Between Hours of CPAP Use and Achieving Normal Levels of Sleepiness and Daily Functioning